Quality Assurance
Procedures
| Document Description | Price (USD) | Click To Purchase |
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Document Title: A List of Required GMP Procedures Document Purpose: To provide a proposed list of SOPs that the manufacturing facility needs to develop to fulfill the basic GMP requirements This is to ensure that there are Procedures in place for every operation/activity the company carries out.
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52.50 $ |
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Document Title: Communication with Regulatory Authorities Document Purpose: To define the requirements for reporting and retaining information compiled from communications with local regulatory authorities.
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21.00 $ |
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Document Title: Corrective and Preventive Action Policy (CAPA) Document Purpose: The purpose of this document is to describe the approach to review quality system data to identify, correct, and prevent non-conformities.
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52.50 $ |
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Document Title: Dietary Supplements Internal Audit Checklists (US FDA Parameter) Document Purpose: The purpose of this procedure is to establish the tool for self-inspection and second party audit requirements to ensure that the facility is fulfilling US FDA regulations as indicated in USA Department of Health and Human Services Food and Drug Administration 21 CFR Part 111, final rule guidance document on “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements”.
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420.00 $ |
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Document Title: Documents Creation (SOP on SOPS) Document Purpose: To describe the process for creating, updating, or revising the corporate, standard operating procedures (SOPs), policies and guidelines. All referred to collectively, herein, as "documents”.
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31.50 $ |
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Document Title: Documents Distribution and Control Document Purpose: The purpose of this document is to establish the system to control and manage documents distribution among corporate employees. This is to assure that all employees are updated and well-knowledgeable about the corporate procedures and policies changes.
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52.50 $ |
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Document Title: Drug Internal Audit Checklists (Health Canada Parameter) Document Purpose: The purpose of this procedure is to establish the tool for self-inspection and second party audit requirements, based on Health Canada; Drugs & Health Products Regulations (GMPs Guidelines, 2018 Edition, (GUI-0001).
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315.00 $ |
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Document Title: Functions of Quality Assurance Department Document Purpose: This guideline is to describe the function and specify the responsibility of the company Quality Assurance Department (QAD). Also, to indicate the manufacturing & QA personnel competency needs and the minimum requirements to establish an adequate sanitation program including the employee’s hygiene.
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73.50 $ |
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Document Title: Good Documentation Practices Guideline Document Purpose: This guideline provides the framework for documentation management. The framework includes document development process, document values, property, categories, types, and document templates.
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105.00 $ |
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Document Title: Management of Information Request and Deficiency Notice Document Purpose: To specify the process for managing the information requests, deficiency notices or refusal letter that received from local regulatory authorities.
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31.50 $ |
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Document Title: Natural Health Products Internal Audit Checklists (Health Canada Parameter) Document Purpose: The purpose of this procedure is to establish the tool for self-inspection and second party audit requirements to ensure that the facility is filling Health Canada regulations as indicated in the Good Manufacturing Practices Guideline Document (Natural and Non-prescription Health Products Directorate, December 1, 2015 - Version 3.0)
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210.00 $ |
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Document Title: Product Manufacturing; Documentation Requirements Document Purpose: This document is to establish the documentation requirements (SOPs & Records), that needed by Health Products manufacturing site.
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31.50 $ |
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Document Title: QA Policy: Internal & Suppliers Audits Document Purpose: The purpose of this document is to define the requirements, responsibilities, and procedures to conduct a periodic and planned audit to ensure that corporate practices are fulfilling the current Good Manufacturing Practices regulations.
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52.50 $ |
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Document Title: QA Policy: Regulatory Inspections Practices Document Purpose: The purpose of this document is to describe the usual governmental inspection practices and recommended specific methods and standards for responding to such inspectional activities.
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105.00 $ |
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Document Title: Records Retention and Data Storage Document Purpose: To establish the procedure to fulfill the regulatory authority’s records retention requirements and to describe the process for storage of data by corporate headquarter.
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21.00 $ |
